Zhen Jiang Shi

This research aims to evaluate the effects of litifilimab (BIIB059), a monoclonal antibody, in adults with active subacute or chronic cutaneous lupus erythematosus (CLE), with or without systemic lupus erythematosus (SLE). Participants have active skin symptoms of CLE that have not improved with antimalarial therapy or had difficulties continuing that treatment. The study focuses on reducing skin disease activity using several scores including CLA-IGA-R and CLASI, while also assessing safety, immune response, and quality of life. Participants will be randomly assigned to receive either litifilimab or a placebo injection under the skin every four weeks during a 24-week double-blind period where neither participants nor researchers know which treatment is given. After this, all participants will receive litifilimab injections every four weeks for an additional 28 weeks. Those who complete the treatment may join a long-term extension study or enter a follow-up safety period lasting up to 24 weeks. Total participation may last up to 80 weeks. Throughout the study, researchers will monitor skin disease activity using the CLA-IGA-R erythema score and the CLASI-A activity score to see how many participants improve. They will also assess safety, tolerability, immune system effects, and participants' quality of life using questionnaires. These evaluations occur regularly during both treatment periods and follow-up to understand the impact of litifilimab on CLE symptoms and overall health.

Researchers are evaluating the safety and effectiveness of a new treatment using allogenic CAR-T cells called RN1101, which target CD19 and BCMA proteins, in patients with relapsed or refractory B-cell or plasma cell-derived malignant tumors. This early phase 1, open-label pilot study plans to enroll 21 patients to understand how well RN1101 works and how safe it is for these blood cancers, including types such as B-cell lymphoma and multiple myeloma. The study also aims to explore how the CAR-T cells expand, persist, and affect cancer cells expressing CD19 or BCMA. Participants will receive a single intravenous infusion of RN1101 CAR-T cells. There is a dose-escalation design to find the best dosing for safety and efficacy. The treatment targets malignant cells by recognizing CD19 and BCMA markers. Patients must have relapsed or refractory disease and meet other health criteria to receive the infusion. The study does not include a comparator group and focuses on this investigational treatment alone. During the study, participants will be monitored for up to 24 weeks after the infusion to assess the occurrence and severity of any adverse events. Regular evaluations will include clinical assessments, laboratory tests, and monitoring of cancer status to evaluate treatment effects and safety. Follow-up visits will help researchers understand how the CAR-T cells behave in the body and their impact on the disease. The total duration of participation depends on follow-up but includes initial treatment and several months of observation.

Researchers are studying the safety and effectiveness of anti-CD19 CAR NK cells (KN5501) in patients with relapsed or refractory B-cell related autoimmune diseases. This early phase 1, single arm, open-label pilot study plans to enroll 15 patients in a dose-escalation trial with two dose levels: 6 x 10^9 cells and 9 x 10^9 cells. The study aims to assess the safety, feasibility, and effectiveness of KN5501, as well as explore its ability to expand, persist, and deplete CD19 positive B cells in these patients. Participants will first receive chemotherapy with Fludarabine (30 mg/m2 per day) and Cyclophosphamide (300 mg/m2 per day) on days -5, -4, and -3, followed by an infusion of anti-CD19 CAR NK cells. The treatment involves close monitoring of adverse events and dose-limiting toxicities. The trial does not include a comparison group and focuses on the administration and effects of KN5501 in this patient population. During the study, researchers will monitor for dose-limiting toxicities and treatment emergent adverse events at multiple time points: within 4 weeks after infusion and again at 12, 24, 36, and 52 weeks post-infusion. Participants will undergo assessments to evaluate safety and treatment response over one year. The total involvement includes these follow-up periods to ensure thorough safety and effectiveness evaluation of the investigational therapy.

This research aims to evaluate the efficacy, safety, and immune response to HB0017 injection given in different dosing schedules for treating adults with moderate to severe plaque psoriasis. It is a randomized, double-blind phase 2 trial focused on people aged 18 to 75 who have had chronic plaque psoriasis for at least six months and meet specific severity criteria. The study seeks to explore how well HB0017 works and how safe it is for this patient group. Participants will receive HB0017 injections in one of three dosing regimens: 300 mg every 12 weeks, 300 mg every 8 weeks, or 150 mg every 4 weeks. These different administration schedules will be compared to assess their effects. The study is conducted across multiple centers and maintains blinding to reduce bias. During the study, researchers will monitor participants to see what proportion achieve significant skin improvement by week 12, using measures like the Psoriasis Area Severity Index (PASI 90 response) and Static Physician Global Assessment (sPGA 0/1). Safety and immune responses will also be assessed. Participants will be regularly evaluated to track treatment effects and any adverse events throughout the trial period.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are evaluating the safety and effectiveness of MC2-01 cream in treating Chinese adults aged 18 years and older with plaque psoriasis affecting the body (trunk and/or limbs). This phase 3, multi-center, randomized, investigator-blinded study compares MC2-01 cream to both calcipotriol and betamethasone dipropionate gel and a vehicle cream. The study includes screening, treatment, and safety follow-up periods to thoroughly assess the treatment's impact. Participants receive one of three treatments: MC2-01 cream (containing calcipotriene and betamethasone dipropionate), CAL/BDP gel (calcipotriol and betamethasone dipropionate gel), or a vehicle cream without active ingredients. Treatments are applied during the treatment period following the study protocol. The design allows comparison of MC2-01 cream’s efficacy and safety against the gel and vehicle. During the study, participants undergo evaluations including physician assessments using the Physician's Global Assessment (PGA) to measure treatment success on the body after 8 weeks. Researchers monitor safety and treatment response through scheduled visits covering screening, treatment, and follow-up phases. Participation involves completing visits as required by the protocol to ensure comprehensive data collection over the study duration.

Researchers are evaluating the protective efficacy and safety of a recombinant herpes zoster vaccine called LZ901 in healthy adults aged 40 years and older. This phase 3, randomized, double-blind, placebo-controlled trial aims to protect adults against shingles caused by the varicella zoster virus. The study will enroll about 26,000 participants to assess how well the vaccine works compared to a placebo and to examine safety and immune response. Participants will receive two injections of either the LZ901 vaccine or a placebo containing an aluminum hydroxide adjuvant on day 0 and day 29. The vaccine is made from a glycoprotein E fusion protein produced in CHO cells, combined with an aluminum hydroxide adjuvant to enhance the immune response. A subgroup of about 3,000 participants will be involved in testing the consistency of different vaccine batches and will receive three different vaccine batches or placebo. This subgroup will be followed for up to 36 months to evaluate immune response persistence. Throughout the study, participants will attend multiple visits including on-site and in-person follow-ups (16 visits for most, 24 for the immunization subgroup). Researchers will perform tests at screening and monitor vaccine efficacy 30 days after full immunization. They will also evaluate safety, immune responses, batch consistency, and the vaccine's effect on reducing the severity and prevention of postherpetic neuralgia. The trial involves detailed monitoring and follow-up over several years to assess long-term outcomes.

Researchers are evaluating ziltivekimab as a treatment for people living with heart failure and inflammation. This Phase 3 study compares ziltivekimab to a placebo in participants with heart failure who have mild to preserved ejection fraction and systemic inflammation. The study aims to assess the effect of ziltivekimab on cardiovascular death, heart failure hospitalization, or urgent heart failure visits over a period of up to 4 years. Participants will receive monthly injections of either ziltivekimab or a placebo using a pre-filled syringe or a pen-injector. The study medication is administered subcutaneously once a month for up to 4 years. The trial includes up to 20 clinic visits during which participants will be monitored and assessed. During the study, participants will use a study app on their phone to record all injections and complete questionnaires. Researchers will monitor participants for key outcomes like cardiovascular events and heart failure episodes from the time of randomization until the end of the study. Safety and health status will be regularly evaluated throughout the study period, which may last up to 48 months.

The trial investigates BBT001 in healthy volunteers and adults with moderate to severe atopic dermatitis in a Phase 1 randomized, blinded, placebo-controlled study. It aims to evaluate safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics, and clinical activity in these two groups. The study includes participants aged 18 to 65 years with specific health criteria and disease severity for atopic dermatitis patients. The study has two parts: Part A administers a single ascending dose of BBT001 or placebo to healthy volunteers in sequential dose groups. Part B involves giving seven repeated ascending doses of BBT001 or placebo to patients with moderate to severe atopic dermatitis. Both parts include placebo control and careful dosing schedules to assess effects over time. Participants will be monitored for adverse events, changes in vital signs, blood tests, physical exams, and ECG results up to day 141 for Part A and day 169 for Part B after the first dose. The study includes assessments of skin condition, pruritus severity, and overall safety. The total study duration and follow-up periods are structured to evaluate safety and clinical outcomes comprehensively.

Researchers are evaluating the effectiveness and safety of brenipatide compared to a placebo in adults with Alcohol Use Disorder (AUD) and hazardous alcohol use. This Phase 3, multicenter, randomized, double-blind study aims to understand if brenipatide can help participants reduce or stop drinking. The study lasts approximately 56 weeks and focuses on changes in drinking patterns using the Timeline Followback Method (TLFB). Participants will receive either brenipatide (LY3537031) or a placebo, both administered by subcutaneous injection. Participants who cannot self-inject will have assistance from a trained support person. They are expected to store and use the blinded study drug as directed, maintain electronic and paper diaries, and complete questionnaires throughout the study. During the study, participants will have scheduled visits to monitor their progress, including assessments of drinking behavior and safety evaluations. Researchers will measure changes in alcohol use patterns up to 56 weeks. Participants must be motivated to reduce or stop drinking and be available for all study visits and procedures. Safety and adherence will be closely monitored throughout the trial.